Effects of Rehabilitation in Patients With Stable Chronic Heart Failure

NCT03538249 | Completed

• 1 other identifier: 0H6BKP01G84
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Heart failure (HF) is a major public health problem. This is the first cause of hospitalization and mortality of about 65 years old. This syndrome is characterized by a poor prognosis and a high cost of care. Thus, new strategies for treatment and prevention of the HF are among the major challenges facing health sciences today. The management of HF requires multimodal approach it involves a combination of non-pharmacological and pharmacological treatment, Besides improvements in pharmacological treatment, supervised exercise programs are recommended for all patients with HF as part of a non-pharmacological management but many questions regarding exercise training in HF patients remain unanswered. Even simple questions such as the best mode of training for these patients are unclear. The aim of this study

1. 1.First, to characterize the physiological functions involved in the genesis of exercise intolerance and dyspnea especially muscle function (respiratory and skeletal), and cardiopulmonary patients suffering from chronic HF.
2. 2.Second, to study and compare the effects of different rehabilitation programs and prove the superiority of the combination of three training modalities program: aerobic training (AT), resistance training (RT) and inspiratory muscle training (IMT).

Conditions

Heart Failure; Aerobic Exercise; Quality of Life; Respiratory Muscle Training; Strength Training; Exercise Intolerance; Cardiac Rehabilitation

Keywords

Heart Failure; Aerobic Exercise; Respiratory Muscle Training; Strength Training

Outcome Measures

Primary Outcomes (1)

• Change in Minnesota Living with Heart Failure Questionnaire (MLWHF)

  The Quality of life was assessed using the Minnesota Living with Heart Failure Questionnaire (MLWHF). the minimum score is 0 and the maximum score is 105. the total score should decrease to indicate the amelioration of the quality of life.

  Baseline and 12 weeks

Secondary Outcomes (12)

• Change in Forced Vital Capacity (FVC)

  Baseline and 12 weeks

• Change in Forced Expiratory Muscle Volume in one second (FEV1)

  Baseline and 12 weeks

• Change in Left Ventricular Ejection Fraction (LVEF)

  Baseline and 12 weeks

• Change in Left Ventricular End Systolic and Diastolic Diameter (LVESD and LVEDD)

  Baseline and 12 weeks

• Change in Maximal Inspiratory Pressure (MIP)

  Baseline and 12 weeks

Study Arms (6)

Aerobic training

EXPERIMENTAL

Patients follow an alternating aerobic training using a treadmill at an intensity of 60% of maximum heart rate, 3 mn and 3 mn working off an alternative way.To ensure progressive overload appropriate, we adjust moderate intensity aerobic exercise every two weeks with an overall 5% increase in heart rate.

Other: Aerobic training

Inspiratory muscle training

EXPERIMENTAL

The inspiratory muscle training involves a high intensity endurance training to 60% of PI, max. We recalculate the individual SPImax and PImax in each training session. Patients use the driving tool inspiratory muscle.

Other: Inspiratory muscle training

Resistance training

EXPERIMENTAL

The resistance should be measured on 1 RM (Repetition Maximum) for each muscle group. The exercises are performed in three sets of ten repetitions of exercises at 60% of 1RM intensity recalculated every two weeks training.

Other: Resistance Training

Control

NO INTERVENTION

The control group patients were allocated to a non-training time period, during which they were told to continue their life as before enrollment.

Aerobic and Inspiratory training

EXPERIMENTAL

Note that the Aerobic and Inspiratory group participant undergone same protocols of inspiratory and aerobic training stated above, with almost a 5 minutes rest in between.

Other: Aerobic and Inspiratory training

Combined

EXPERIMENTAL

Note that the Aerobic, Inspiratory and resistance group participant undergone same protocols of inspiratory and aerobic training stated above, with almost a 5 minutes rest in between.

Other: Combined

Interventions

Aerobic training OTHER

Aerobic training

Inspiratory muscle training OTHER

Also known as: Respiratory Training

Inspiratory muscle training

Resistance Training OTHER

Also known as: Strength training

Resistance training

Aerobic and Inspiratory training OTHER

Aerobic and Inspiratory training

Combined OTHER

Aerobic, inspiratory and resistance training

Combined

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Congestive heart failure (CHF) due to ischemic or dilated cardiomyopathy.
• Left ejection fraction ≤ 45%.
• NYHA functional class II and III.
• A patient with a diagnosis of CHF for six months including no admission to the hospital or change in medications over the previous 3 months.
• IMW \<70% of predicted

You may not qualify if:

• Pulmonary limitation (forced expiratory volume in 1 s and/or vital capacity of less than 60% of predicted value).
• History of significant cardiac arrhythmia.
• History of myocardial infarction or cardiac surgery (6 months).
• Orthopedic or neurologic disease.
• Non echogenic, Unstable.
• Poorly controlled blood pressure.
• End-Stage HF (on the waiting list for transplantation or LVAD).

Sponsors & Collaborators

• Lebanese University: lead

Related Publications (1)

• Sadek Z, Salami A, Youness M, Awada C, Hamade M, Joumaa WH, Ramadan W, Ahmaidi S. A randomized controlled trial of high-intensity interval training and inspiratory muscle training for chronic heart failure patients with inspiratory muscle weakness. Chronic Illn. 2022 Mar;18(1):140-154. doi: 10.1177/1742395320920700. Epub 2020 May 5.

  PMID: 32370544 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Breathing Exercises; Resistance Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All evaluations were performed by investigators who were unaware of the allocation of patients to different interventions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical Therapy Center

Model Details: Interventions Aerobic exercise training Patients follow an alternating aerobic training using a treadmill at an intensity of 60% of maximum heart rate, 3 mn and 3 mn working off an alternative way.To ensure progressive overload appropriate, we adjust moderate intensity aerobic exercise every two weeks with an overall 5% increase in heart rate. Inspiratory muscle training The inspiratory muscle training involves a high intensity endurance training to 60% of PI, max. We recalculate the individual SPImax and PImax in each training session. Patients use the driving tool inspiratory muscle. Resistance training The resistance should be measured on 1 RM (Repetition Maximum) for each muscle group. The exercises are performed in three sets of ten repetitions of exercises at 60% of 1RM intensity recalculated every two weeks training.

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 29, 2018
• Study Start: January 1, 2015
• Primary Completion: October 15, 2017
• Study Completion: January 1, 2018
• Last Updated: May 29, 2018

Record last verified: 2018-05